Process Development and Manufacturing Associate

Process Development and Manufacturing Associate at Stanford University summary:

The Process Development and Manufacturing Associate supports viral vector biomanufacturing for clinical cell and gene therapies in a cGMP and BSL2 environment. Responsibilities include performing manufacturing campaigns, process development, technology transfer, and maintaining lab operations and compliance documentation. The role requires knowledge of biological principles, aseptic techniques, and the ability to work with clinical manufacturing schedules and safety requirements.

The Laboratory for Cell & Gene Medicine (LCGM) at Stanford University School of Medicine is seeking a Manufacturing Associate for the Viral Vector team. The LCGM is a ~20k ft2 multi-product Cell and Gene Therapy manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children’s Hospital (LPCH) and Stanford Health Care (SHC).

It supports by developing first in human cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in Phase I/II clinical trials.

The Associate hired for this role will have a role focused on clinical Viral Vector products. Work is to be consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases. This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.

Duties include:

· Plan, prepare for and perform viral vector materials biomanufacturing campaigns typically as an operator or a verifier. Prepare final formulated viral vector products for clinical trials within production timelines and manufacturing schedules.

· Perform components of process development and technology transfer for viral vector production, and optimization activities in transitioning and translating pre-clinical, benchtop research into clinical phase. This includes testing and process optimization for upstream and downstream processing at the small scale manufacturing platforms and using novel bioreactors.

· Help with general lab maintenance as needed; maintain lab stock, manage chemical inventory and safety records, and provide general lab support as needed

· Identify, document and report operating excursions and facility deficiencies; make recommendations for process improvements and documentation improvements including Standard Operating Procedures (SOP) and manufacturing Batch Records (BRs).

· Independently track, verify and ensure cGMP grade raw materials for biomanufacturing. Identify and plan for supply chain and raw materials lead times for scheduled campaigns.

· Perform preparation activities of assigned cGMP manufacturing projects.

·

*- Other duties may also be assigned

All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.

Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs.

The pay range for this position working in the California Bay area is $40.52 to $44.33 hourly.

DESIRED QUALIFICATIONS:

· Knowledge and following SOPs and batch records preferred

· Aseptic technique and cell culture experience preferred

· Experience with viral vector production, molecular biology, upstream and downstream processing preferred

· cGMP experience is preferred

· Ability to occasionally work into the…